JP2013521953A - Diagnostic system - Google Patents

Abstract

A composite diagnostic system comprising a support member, the support member comprising a membrane penetrating element and a body fluid collection point arranged to collect body fluid exiting by applying the membrane penetrating element to a user's body; A composite diagnostic system comprising a support member, the test device having a test member disposed on the support member so that the body fluid is in contact with the test device during use.
[Selection] Figure 20

Description

  The present disclosure relates generally to integrated systems for diagnosis in humans and animals.

  Systems are known that perform relatively quick tests, assays or diagnoses relatively easily. However, personally performing these relatively rapid tests, assays or diagnoses may require complex instructions and multiple devices.

A composite diagnostic system comprising a support member, the support member comprising:
A membrane penetrating element;
A bodily fluid collection element arranged to collect bodily fluid exiting by applying said membrane penetrating element to a user's body;
An inspection instrument that is disposed on the support member such that the body fluid is in contact with the test material when in use; and
A combined diagnostic system comprising a support member is disclosed.

  In one form, the test equipment includes a test strip disposed on the combined diagnostic system. In one form, the said test equipment contains the test | inspection cassette arrange | positioned at the said composite diagnostic system. In one form, the inspection device includes a cartridge. In one form, the test instrument includes an integrated circuit disposed within the diagnostic system. In one form, the inspection instrument includes a reagent tube. In one form, the test instrument is removably disposed within the diagnostic system.

  In one form, the membrane penetrating element includes a lancet or incision system that includes a lancet tip, the lancet being in a rest position where the lancet tip is located within the support member, and the lancet tip beyond the support member. It can be moved between extended operating positions.

  In one form, the system further comprises a lancet activator, the lancet being movable from the rest position to the operating position by actuation of the lancet activator.

  In one form, the lancet is removably connected to the support member. In one form, the lancet is incorporated into the support member.

  In one form, the lancet activator is connected to the support member.

  In one form, the system further comprises a tank configured to contain a physiologically acceptable solution, the tank containing the physiologically acceptable solution together with the body fluid in use. It is comprised so that it may contact with.

  In one form, the vessel is incorporated into the support member.

  In one form, the support member further comprises a solution delivery actuator, and the physiologically acceptable solution is delivered to the test device by actuation of the solution delivery actuator.

  In one form, the physiologically acceptable solution is a buffer.

  In one form, the system further comprises a sanitizing cotton locator, which is a functional part within the support member, configured to associate an alcohol sanitizing cotton with the system. In one form, the sanitizing cotton locator includes a mark, in one form, the sanitizing cotton locator includes a recess, and in one form, the sanitizing cotton locator includes a recessed enclosure or an alternative retainer.

  In one form, the system further comprises a drying pad locator or function disposed on the support member that associates the drying pad with the system.

  In one form, the system further comprises a bandage feature located on or in the surface of the support member configured to associate a bandage with the system. In one form, the bandage function includes a recessed or recessed enclosure that houses and holds the bandage.

  In one form, the system further comprises indicia indicating how to use the system.

  In one form, the system is hand-held. In one form, the system is configured to be held with one hand. In one form, the system is configured for self-testing.

  In a second aspect, the membrane penetrating element is configured to be held by hand, and a bodily fluid collection point arranged to collect bodily fluid exiting by applying the membrane penetrating element to a user's body, A composite diagnostic system is disclosed comprising two or more of the inspection instruments disposed on the support member such that the body fluid is in contact with the inspection instrument when in use.

  In one form, the portion of the main body that includes the membrane-penetrating element and the body fluid collection point is separable from the portion of the main body that includes the testing instrument.

  In a third aspect, a composite diagnostic system is disclosed, further comprising an interconnect element configured to allow the system to interface with a diagnostic instrument. .

  In one form, the interconnection element includes a removable portion of the system configured to engage a diagnostic instrument.

  In one form, the removable portion includes the inspection device.

  In one form, the interconnect element includes an opening configured to allow a diagnostic instrument to interconnect with the system.

  In one form, the opening is arranged so that the testing instrument can be interconnected with the diagnostic instrument through the opening.

  Preferred embodiments will now be described by way of example only with reference to the accompanying drawings.

1 is an isometric view of one embodiment of the present system. FIG. 2 is a side view of the embodiment of FIG. 1. It is a 2nd side view of embodiment of FIG. It is a 3rd side view of embodiment of FIG. It is a 4th side view of embodiment of FIG. FIG. 3 is an isometric view of a second embodiment of the system. FIG. 7 is a top view of the embodiment of FIG. FIG. 6 is an isometric view of a third embodiment of the system. FIG. 9 is a side view of the embodiment of FIG. FIG. 9 is a second side view of the embodiment of FIG. FIG. 9 is a third side view of the embodiment of FIG. FIG. 9 is a fourth side view of the embodiment of FIG. It is a top view of 4th Embodiment of this system. FIG. 14 is a side view of the embodiment of FIG. 13. FIG. 14 is a bottom view of the embodiment of FIG. 13. It is a top view of 5th Embodiment of this system. FIG. 17 is an isometric view of the embodiment of FIG. FIG. 17 is an isometric view of the embodiment of FIG. 16 in the closed position. It is a top view of 6th Embodiment of this system. FIG. 20 is a perspective view of the embodiment of FIG. 19. FIG. 20 is a cross-sectional view of the embodiment of FIG. It is a perspective view in the 1st position of 7th Embodiment of this system. FIG. 23 is a top view of the embodiment of FIG. FIG. 23 is a cross-sectional view of the embodiment of FIG. FIG. 23 is a perspective view of the embodiment of FIG. 22 at a second position. FIG. 23 is a top view of the embodiment of FIG. 22 at a second position. It is a perspective view in the closed position of 8th Embodiment of this system. FIG. 28 is a perspective view of the embodiment of FIG. 27 in use. FIG. 28 is a perspective view of the embodiment of FIG. 27 in use.

  With reference to FIGS. 1-5, a combined diagnostic system 10 is disclosed. The diagnostic system 10 comprises a support member 20 composed of a body 21 in the form of a housing having six faces. The main body 21 includes an upper surface 22, a bottom surface 23, and side surfaces 24.

  The described embodiment is in the form of a size that the user can hold in hand. However, to those skilled in the art, the system can be designed for use on a tabletop or in any alternative arrangement and orientation, and the embodiments described below describe use on a tabletop. You will understand.

  The diagnostic system further comprises an integrated lancet 28. The assembled lancet is positioned in one side surface 24 of the main body 21. The built-in lancet 28 is positioned so that the finger pad hole 29 is adjacent to the built-in lancet 28. The built-in lancet includes a lancet tip (not shown) that is movable between a rest position where the lancet tip fits within the body 21 and an operating position where the lancet tip extends from the body. . In the operating position, the lancet tip extends from the body so that when the lancet moves from the rest position to the operating position, a finger placed in the finger pad hole is punctured by the lancet.

  In use, activation of the lancet from the rest position to the operating position is performed by depressing the lancet activator 30 arranged on the main body. The contact with the lancet activator 30 moves the tip of the lancet to the finger pad hole 29, and punctures a finger placed in the hole or a body part instead of the finger.

  When the user or clinician punctures the user's finger with the lancet, the user's finger is moved onto the blood collection window 32, and body fluid, in this case, blood, is collected in the liquid collection window 32. The collection window 32 is proximate to the hole 29 to allow the user to easily move the punctured finger from the hole 29 to the window without depositing liquid other than the collection window 32. Has been placed.

  The diagnostic system further comprises a physiologically acceptable solution, such as a buffer that maintains blood or other bodily fluids. A solution delivery actuator 35 is disposed on the diagnostic system. Upon contact with the solution delivery actuator, the buffer solution is released from the inner tank and delivered to the test equipment incorporated in the diagnostic system 10. The test instrument can be a lateral flow test strip, a vertical flow test strip, a solid phase test instrument, an agglutination test instrument, a cartridge or reagent tube, or any element that incorporates a reagent adapted to be mixed with a body fluid, a liquid sample A card, assay, test strip or built-in electrical circuit incorporating a holding material, or configured to hold a sample and configured to allow a diagnostic test to be performed on the instrument Any equipment can be included.

  The diagnostic system further comprises a result window 41 arranged to easily display the results of any diagnostic tests performed.

  An alcohol sanitizing cotton locator 45 in the form of a recess into which an alcohol sanitizing cotton and dry wipe can be inserted is arranged on the side surface 24. The recess 45 is covered with a seal 46 such as a foil seal or a plastic seal.

  A bandage locator 48 is located on a further side of the diagnostic system. The adhesive bandage locator is in the form of a recess in which an adhesive bandage such as Band Aid (trademark) is received.

  On the side surface of the diagnostic system 10, a mark 72 indicating the order of using these side surfaces is marked. This simplifies the process of using the system and allows the home user to take necessary steps with confidence. By arranging the finger pad hole 29, the liquid collection window 32, the solution delivery actuator 35, the alcohol disinfecting cotton locator 45, and the bandage locator 48, the process steps can be easily advanced. This allows an intuitive movement with respect to the surface of the system 10. As described above, the lancet activator 30 is located near the liquid collection window 32, the liquid collection window 32 is located near the solution delivery actuator 35, and the solution delivery actuator 35 is arranged near the band aid locator 48. Following the steps in the order indicated by the indicia 72 allows a series of movements with respect to the system 10.

  In the second embodiment of the present diagnostic system shown in FIGS. 6 and 7, the diagnostic system 50 comprises a body 51 in the form of a substantially H-shaped housing.

  In the illustrated form, the housing includes an integrated lancet 52 that substantially passes through the housing 51. The lancet 52 is movable between a stationary position where the tip of the lancet is accommodated in the main body 51 and an operating position where the tip of the lancet extends from the main body 51. The lancet 52 is operated by a lancet activator 53 disposed at one end of the main body 51.

  Although the illustrated form includes a membrane penetrating element in the form of a lancet, those skilled in the art will recognize that a membrane penetrating element allows a user to penetrate a membrane such as skin to allow a liquid sample to be drawn. It will be appreciated that any piercing element, cutting element, cutting element, piercing element or piercing element that makes it possible.

  The diagnostic system further comprises a blood collection window 54 on which the user places his / her pierced finger to collect blood that comes out of the finger after the lancet has punctured the finger. The blood collection window is arranged in a line with the test equipment incorporated in the diagnostic system 50. A receptacle 55 for buffer solution is arranged on the diagnostic system 50. The receptacle 55 is in the form of a sachet of buffer solution that can be manually added to the blood in the blood collection window 54.

  Lateral flow test strip 56 extends across one portion of the diagnostic system such that blood collection window 54 and result window 57 are both positioned over lateral flow test strip 56. Buffer 55 is added to blood collection window 54 and the result appears in result window 57.

  In use, the user peels off the foil 60 disposed so as to cover the alcohol sanitizing cotton 61 and the dry wiping material 62. The user then cleans his / her finger with alcohol-sanitized cotton 61 and wipes with a dry wipe 62. The user then places a finger pad on point 63 of the incorporated lancet 52.

  Activation of the lancet is effected by contact with the button 53. In the illustrated form, activation of the lancet includes extending the lancet penetrating element and retracting the lancet penetrating element into the housing to provide safe storage and disposal. In the extended position, the penetrating element is configured to incise, puncture, cut, pierce, or otherwise penetrate the user's finger located at point 63. Next, blood is collected in the blood collection window 54. The physiologically acceptable solution receptacle 55 is then removed from the body and the solution is added to the blood collection window 54. The lateral flow test strip extends across the lateral flow test strip 56 of the body 51 so that the result can be read in the result window 57.

  In a third embodiment, the diagnostic system 70 comprises a body 71 in the form of a housing having six faces. These planes are marked 72 with the order in which the planes are used. The user first peels off the foil 73 from the alcohol sanitized cotton 74 and the dry wipe 75 placed in an alcohol sanitized cotton locator in the form of a recess 76 on one side of the diagnostic system 70. The user cleans his finger with alcohol sanitized cotton and then inserts his finger into the finger pad recess 78 on the second side of the diagnostic system 70. An integrated lancet 79 is positioned in this plane and is actuated by a lancet activator 80. When the user contacts the lancet activator 80, the tip of the lancet extends from the main body 71 and punctures a finger in the hole 78. The lancet tip then retracts. The user then has his blood collected at the blood collection window 82 on the third side of the diagnostic system 70.

  A solution delivery actuator 84 is disposed on the same surface of the diagnostic system 70 as the blood collection window 82. Depressing the solution delivery actuator delivers a physiologically acceptable solution or buffer to the lateral flow test strip.

  The lateral flow test strip is not visible from outside the diagnostic system 70, but is incorporated into the system. The blood collected in the blood collection window 82 and the buffer solution released when the solution delivery actuator 84 is pressed together allow the test strip or other test equipment to present the result in the result window 86. . The user then peels the adhesive strip from the adhesive bandage locator 87 located on the fourth side of the system. The punctured finger can then be wrapped with a bandage.

  A fourth embodiment is shown in FIGS. In this embodiment, the diagnostic system 100 comprises a body 101 in the form of an elongated housing. The body 101 includes a finger pad hole 102 disposed adjacent to the lancet 103. The lancet 103 is incorporated in the main body 101, and is movable between a position where the tip of the lancet is accommodated in the main body 101 and a position where the tip of the lancet extends from the main body to the finger pad hole 102.

  The diagnostic system includes a lancet activator 104 that operates to move the lancet between a rest position where the lancet tip fits within the body 101 and an actuation position where the lancet tip extends to the finger pad recess 102. In addition. The back surface of the main body 101 includes a solution delivery actuator in the form of a push button 106 in addition to the blood collection window 107 and the result window 108. In use, the user inserts his / her finger into the finger pad hole 102 and the finger pad presses against the built-in lancet 103. The user then activates the lancet 103 by pressing the lancet actuator 104. This acts to puncture a finger. The user then draws blood into the blood collection window 107 and presses the solution delivery actuator 106 so that a buffer solution or other physiologically acceptable solution is incorporated into the blood in the blood collection window 107 and the diagnostic system. Allows contact with lateral flow test strips. A lateral flow test strip then presents the results in the results window 108.

  A fifth embodiment of the diagnostic system is shown in FIGS. In this form, the system is in the form of a kit and the support member includes a hard cover case 110. The hard cover case is hinged along the central hinge 111 and, when opened, a removable incision system 112, an alcohol sanitized cotton / dry wipe locator 113, a blood collection window 114, a lateral flow test strip 115, The result window 116, the solution delivery actuator 117, and the bandage locator 118 appear.

  In use, the user removes the foil from the alcohol sanitized cotton / dry wipe locator 113 to clean the finger for use. The user then removes the removable lancet 112 from the hard cover case 110 and places his finger on the puncture end 118 of the incorporated lancet 112. The user then depresses lancet actuator 119 and punctures the finger.

  Blood is collected in a blood collection window 114 above the test strip 115. A buffer solution reservoir 120 is positioned within the body and is connected to the test strip 115 by a channel 121. The user slides the solution delivery actuator 117 forward to direct the buffer to the test strip and the results are presented in the result window 116.

  In the sixth embodiment shown in FIGS. 19-21, a combined diagnostic system 140 is disclosed. The diagnostic system 140 may be handheld in one form. Alternatively, the system may be sized for use as a table top system. The diagnostic system 140 comprises a support member 142 comprised of a body 143 in the form of a housing having an elongated elliptical shape. The body 143 includes a top surface 144, a bottom surface 145, and side surfaces 146 and extends from the distal end 147 where the lancet is positioned to the proximal end 148.

  The diagnostic system further comprises an integrated lancet 149. The assembled lancet is positioned at the distal end 147 of the body 143 and is surrounded by the outer wall of the body. The lancet tip 151 is positioned inside the main body 142 in the stationary position. The lancet tip 151 is positioned to extend from the body 142 when the lancet is activated. As the lancet moves from the rest position to the operative position, in the operative position, the lancet tip 151 extends from the body such that a finger placed at the distal end is punctured by the lancet. The lancet tip 151 is then retracted into the body 143.

  In use, activation of the lancet from the rest position to the operative position is accomplished by depressing a lancet activator 153 extending from the distal end 147. The user places his / her finger on the protruding end 155 of the lancet 149, and the lancet activator 153 is pressed by this contact to move the lancet tip 151, so that the finger placed on the distal end 147 or an alternative body part Puncture.

  When a user or clinician punctures a user's finger with a lancet, the user's finger is moved over a liquid collection element 156, which in the illustrated form is a window. Body fluid, in this case blood, is collected at the collection element 156. The collection element 156 is proximate to the distal end 147 to allow the user to easily move the punctured finger to this element without depositing liquid other than the collection element 156. Has been placed.

  Although the collection element 156 is described in the form of a window to which liquid adheres, alternatively, a capillary that can be configured to hold and deposit a quantifiable amount of liquid, an alternative opening Part or recess, loops, wells configured to hold and deposit a small amount of liquid, or any that allows the liquid to be deposited and transferred to, or moved or placed on, test equipment within the system May be in the form of alternative embodiments.

  The diagnostic system further comprises a physiologically acceptable solution, such as a buffer, contained in a buffer pouch 159 that maintains blood or other bodily fluids. A solution delivery actuator 160 is disposed on the diagnostic system. The buffer solution is released from the pouch 159 by contact with the solution delivery actuator 160.

  An inspection instrument in the form of a test strip 162 is disposed under the buffer sachet 159 and the collection window 156. The test instrument in the form shown includes a lateral flow test strip, but a vertical flow test strip, a solid phase test instrument, an agglutination test instrument, a cartridge or reagent tube, or a reagent adapted to be mixed with a body fluid. It may include any element incorporated, a card incorporating a liquid sample carrier, an assay, a test strip, or an integrated electrical circuit.

  The diagnostic system further comprises a result window 164 located on the same plane as the collection window 156 that easily displays the results of any diagnostic tests performed.

  An alcohol sanitizing cotton locator 165 in the form of a mark or recess or other positioning feature that can insert or be accompanied by alcohol sanitizing cotton and dry wipes is provided on the side 146 of the support member as illustrated. Located on the surface.

  A bandage locator 167 is disposed at the proximal end 148 of the diagnostic system 140. The bandage locator is in the form of a slit extending into the body 142 of the system 140 in which a bandage, such as BandAid ™, is received.

  In the seventh embodiment shown in FIGS. 22-26, a combined diagnostic system 140 is disclosed. The diagnostic system 140 comprises a support member 142 comprised of a body 143 in the form of a housing having an elongated elliptical shape. The body 143 includes a top surface 144, a bottom surface 145, and side surfaces 146 and extends from the distal end 147 where the lancet is positioned to the proximal end 148.

  The diagnostic system further comprises an integrated lancet 149. The assembled lancet is positioned at the distal end 147 of the body 143 and is surrounded by the outer wall of the body. The lancet tip (not shown in this form) is positioned inside the body 142 in the rest position. The lancet tip is positioned to extend from the body 142 when the lancet is activated. As the lancet moves from the rest position to the operative position, in the operative position, the lancet tip extends from the body such that a finger placed at the distal end is punctured by the lancet. The lancet tip is then retracted into the body 143 to allow safe storage or disposal of the system.

  In use, activation of the lancet from the rest position to the operative position is accomplished by depressing a lancet activator 153 extending from the distal end 147. The user places his / her finger on the protruding end 155 of the lancet 149, and the lancet activator 153 is pushed by this contact to move the lancet tip to move the finger placed on the distal end 147 or an alternative body part. Puncture.

  When a user or clinician punctures a user's finger with a lancet, the user's finger is moved over a liquid collection element 156, which in the illustrated form is a window. Body fluid, in this case blood, is collected at the collection element 156. The collection element 156 is proximate to the distal end 147 to allow the user to easily move the punctured finger to this element without depositing liquid other than the collection element 156. Has been placed.

  Although the collection element 156 is described in the form of a window to which liquid adheres, alternatively, a capillary that can be configured to hold and deposit a quantifiable amount of liquid, an alternative opening A portion or recess, a loop, well, or any alternative that allows a small amount of liquid to be held and deposited, or allows the liquid to be deposited and transferred to, or moved or placed on, test equipment The form of embodiment may be sufficient.

  The diagnostic system further comprises a physiologically acceptable solution, such as a buffer, contained in a buffer pouch 159 that maintains blood or other bodily fluids. A solution delivery actuator 160 in the form of a slide is disposed on the diagnostic system. The buffer solution is released from the pouch 159 by sliding the solution delivery actuator 160 to the operating position (shown in FIGS. 25 and 26).

  An inspection instrument in the form of a test strip 162 is disposed under the buffer sachet 159 and the collection window 156. The illustrated form of test equipment includes lateral flow test strips, but is alternatively adapted to be mixed with vertical flow test strips, solid phase test equipment, agglutination test equipment, cartridges or reagent tubes, or body fluids. It may include any element incorporating a reagent, a card incorporating a liquid sample holder, an assay, a test strip, or an integrated electrical circuit.

  In one form, the test instrument is configured to interconnect with a diagnostic instrument to perform a diagnosis. In one form, the test instrument is removably engaged with the diagnostic system and configured to interconnect with a diagnostic instrument for diagnosis when removed. For example, the test strip can be removable and can be inserted into a diagnostic instrument for analysis. In another form, a portion of the system, such as a cartridge or liquid retainer that contains test equipment, can be removed from the system for interconnection with a diagnostic instrument.

  Alternatively, the system may include a port or platform for engaging a diagnostic instrument. The port may be in the form of a window or opening that contacts the inspection instrument. In that case, the diagnostic system can be interconnected with a diagnostic instrument to be analyzed and to present the diagnosis.

  The diagnostic system further comprises a result window 164 that is located on the same plane as the collection window 156, which makes it easy to see the results of any diagnostic tests performed. The result window 164 of this embodiment is below the solution delivery actuator 160 when the solution delivery actuator 160 is in the rest position (shown in FIGS. 22 and 23), and the solution delivery actuator 160 is in the operative position (FIGS. 25 and 23). Appears when you come to In the activated position, the collection window 156 is covered by the solution delivery actuator 160.

  An alcohol sanitizing cotton locator 165 in the form of a recess into which an alcohol sanitizing cotton and dry wipe can be inserted is disposed on the upper surface 144.

  A bandage locator 167 is disposed at the distal end 148 of the diagnostic system 140. The bandage locator is in the form of a slit extending into the body 142 of the system 140 in which a bandage, such as BandAid ™, is received.

  27 to 29 show an eighth embodiment of the diagnostic system. The diagnostic system 180 includes a body 181 that includes a sampling section 183 and a diagnostic section 184. The sampling section 183 and the diagnostic section 184 are removably engaged with each other. In the illustrated form, the diagnostic section 184 overlies the sampling section 183 and engages by a connector, clip, interference fit, snap fit or other engagement method.

  The sampling section 183 includes a sampling body 186. The sample collection body 186 is configured to be held with one hand, but can alternatively be placed on the surface. A membrane penetrating element in the form of a lancet (not shown in this form) generally fits within the body 186. The lancet tip (not shown) is positioned to extend from the body through the lancet opening 187 and then retract back into the body in the operating position. The lancet is actuated by the pressure on the lancet actuating element 188.

  In the illustrated form, the membrane penetrating element is described with respect to a lancet, but any other piercing element, piercing element, cutting element, or other penetrating element can be used.

  The sampling section 183 further includes a liquid collection element 190. In the illustrated form, the collection element 190 is in the form of a loop 191, but can include wells, windows, capillaries, or any alternative element for collection.

  The user places a body part, such as a finger, near the lancet opening 187 and activates the lancet by the pressure on the lancet actuating element 188. The lancet penetrates the membrane of the body part and draws out liquid, in this case blood. The user places a body part in contact with the loop 191 and attaches a blood sample to the loop 191.

  The diagnostic section 184 includes a body 193 that rests on the surface in this form. The body includes a liquid attachment opening 194 into which the liquid collection element 190 of the sampling section 183 can be inserted to deposit liquid from the loop 191.

  A test instrument (not shown) is disposed within the body 193 such that liquid from the sampling section 183 interacts with the test instrument.

  In the form shown, the test equipment is in the form of an integrated lateral flow test strip, test strip, cassette, cartridge, integrated circuit or other diagnostic or pre-diagnostic element.

  The diagnostic section 184 further includes a test result window 196 that can display the results of the diagnostic test.

  Although the illustrated form shows a built-in test instrument that provides in-situ diagnostics, those skilled in the art can configure the test instrument to be analyzed elsewhere, so that the diagnostics are separate. It will be appreciated that this can be performed by other diagnostic instruments.

  As best shown in the first and third embodiments, indicia 72 are incorporated into the system to visually instruct the user to perform a series of steps in sequence. In the illustrated embodiment, the mark is in the form of a number, but a graphic mark, a picture mark, a letter mark, or an alternative mark effectively presents a series of steps to provide instructions to the user. It will be clear that you can. In the first embodiment, indicia 72 instruct the user to first perform a step on the surface labeled “1”, ie, clean and wipe the area of skin in preparation for an incision. The user then turns the system to find step “2”, and inserts a finger into the finger pad hole 29 for incision in step “2”. The user then activates the lancet 28. The user turns the system to find step “3”, and attaches blood to the blood collection window 32 in step “3”. Physiologically acceptable solution and blood come into contact with the test equipment and the results are shown in the front result window. The user then turns the system to perform step 4 and applies a bandage to the finger.

  In the third embodiment, the steps are substantially the same, but the step of delivering a physiologically acceptable solution to the test device is performed by actuating an actuator 84 located adjacent to the blood collection window 82. Is called.

  In one form not shown, a separable patient information card or patient information label is attached to the support member.

  In one form not shown, the diagnostic system incorporates a membrane penetrating element, a collection element and test equipment, and in some forms a cartridge incorporating a physiologically acceptable solution such as a buffer, and a test result window. It is modular with a main body. In this form, manufacturing includes, for example, manufacturing the body incorporating the lancet and the cartridge separately. Manufacturing separately allows the selection of specific cartridges to use in a given order. In the appended claims and in the foregoing description of the device, the terms “comprise” or “comprises” or “comprising” unless the context demands otherwise by explicit language or inevitable suggestion. Etc. are used in a generic sense, i.e. not to exclude the presence or addition of further functions in various embodiments of the invention, but to identify the presence of the stated functions. It has been.

Claims (31)

A composite diagnostic system comprising a support member, the support member comprising:
A membrane penetrating element;
A bodily fluid collection point arranged to collect bodily fluid exiting by applying the membrane penetrating element to the user's body;
An inspection instrument that is disposed on the support member so that the body fluid is in contact with the inspection instrument during use;
A combined diagnostic system comprising a support member.   The combined diagnostic system according to claim 1, wherein the inspection instrument includes a test strip disposed in the combined diagnostic system.   The combined diagnosis system according to claim 1, wherein the inspection instrument includes an inspection cassette arranged in the combined diagnosis system.   The composite diagnosis system according to claim 1, wherein the inspection instrument includes a cartridge.   The combined diagnostic system of claim 1, wherein the inspection instrument includes an integrated circuit disposed within the diagnostic system.   The combined diagnosis system according to claim 1, wherein the inspection instrument includes a reagent tube.   The combined diagnostic system according to any one of claims 1 to 6, wherein the inspection device is detachably disposed in the diagnostic system.   The puncture mechanism includes a lancet or cutting system including a lancet tip, wherein the lancet is a stationary position where the lancet tip is located within the support member, and an operating position where the lancet tip extends beyond the support member. The combined diagnosis system according to any one of claims 1 to 7, wherein the combined diagnosis system is movable between the two.   9. The combined diagnostic system of claim 8, wherein the system further comprises a lancet activator, and the lancet is movable from the rest position to the operating position by actuation of the lancet activator.   The combined diagnostic system according to claim 8 or 9, wherein the lancet is detachably connected to the support member.   The combined diagnostic system according to claim 8 or 9, wherein the lancet is incorporated in the support member.   The combined diagnostic system according to claim 9, wherein the lancet activator is connected to the support member.   The system further comprises a reservoir configured to contain a physiologically acceptable solution, wherein the reservoir is in contact with the test equipment along with the body fluid during use. The composite diagnostic system according to any one of claims 1 to 12, wherein the combined diagnostic system is configured as follows.   The combined diagnostic system according to claim 13, wherein the tank is incorporated in the support member.   15. The combined diagnosis system according to claim 13, wherein the support member further includes a solution delivery actuator, and the physiologically acceptable solution is delivered to the test device by operation of the solution delivery actuator.   The combined diagnostic system according to any one of claims 13 to 16, wherein the physiologically acceptable solution is a buffer.   17. The combined diagnosis according to any one of the preceding claims, wherein the system further comprises a sanitizing cotton locator positioned within the support member and configured to associate an alcohol sanitizing cotton with the system. system.   The combined diagnostic system of claim 17, wherein the disinfecting cotton locator includes a mark or recess.   19. The combined diagnostic system of any one of claims 1-18, wherein the system further comprises a dry pad locator disposed within the support member that associates a dry pad with the system.   20. The combined diagnostic system of any one of the preceding claims, wherein the system further comprises a bandage locator in the support member configured to associate a bandage with the system.   21. The combined diagnostic system of claim 20, wherein the bandage locator includes a slit extending into the support.   22. The combined diagnostic system according to any one of the preceding claims, wherein the system further comprises indicia indicating how to use the system.   The combined diagnostic system according to any one of claims 1 to 22, wherein the system is a hand-held size.   24. The combined diagnosis system according to any one of claims 1 to 23, wherein the system is configured to be held with one hand.   The combined diagnosis according to any one of claims 1 to 22, wherein a part of the main body including the membrane-penetrating element and the body fluid sampling point is separable from a part of the main body including the inspection device. system.   A membrane penetrating element configured to be held by a hand, a body fluid collection point arranged to collect body fluid exiting by applying the membrane penetrating element to a user's body, and an inspection device. A combined diagnostic system comprising two or more of inspection devices disposed on the support member so that the body fluid is in contact with the inspection device during use.   27. A combined diagnostic system according to any one of the preceding claims, further comprising an interconnection element configured to allow the system to interconnect with diagnostic equipment.   28. The combined diagnostic system of claim 27, wherein the interconnection element includes a removable portion of the system configured to engage a diagnostic instrument.   29. The combined diagnostic system of claim 28, wherein the removable portion includes the inspection instrument.   28. The combined diagnostic system of claim 27, wherein the interconnect element includes an opening configured to allow a diagnostic instrument to interconnect with the system.   31. The combined diagnostic system of claim 30, wherein the opening is arranged so that the inspection instrument can be interconnected with the diagnostic instrument through the opening.

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